Monitoring Response to Neoadjuvant Chemotherapy in Breast Cancer Using Ultrafast Dynamic Contrasted-Enhancement Magnetic Resonance Imaging
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Complete Pathologic Response (pCR)
研究概览
简要总结
The study will assess whether changes in kinetic parameters of tumor and peritumoral vasculature using ultrafast dynamic contrast enhanced magnetic resonance imaging (DCE-MRI) during neoadjuvant chemotherapy (NAC) are predictive of pathologic complete response (pCR) in patients with breast cancer appropriate for NAC. pCR is defined as having no residual invasive breast cancer or ductal carcinoma in situ.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age 18 years or older;
- •Diagnosis of invasive breast cancer by ultrasound guided biopsy;
- •Planed for receiving neoadjuvant chemotherapy (NAC)
- •Planned definitive breast surgery following completion of NAC.
排除标准
- •Stage IV breast cancer;
- •Previous ipsilateral breast cancer;
- •Previous treatment (chemotherapy or radiation) to involved breast;
- •Medically unstable;
- •Pregnant or nursing.
结局指标
主要结局
Complete Pathologic Response (pCR)
时间窗: 6 Months Post Surgery
The primary aim of this feasibility study is to determine whether ultrafast dynamic contrasted-enhancement magnetic resonance imaging (DCE-MRI) at baseline prior to first cycle neoadjuvant chemotherapy (NAC), after first cycle NAC, and prior to second cycle NAC can accurately predict complete pathologic response (pCR) in women with breast cancer.
次要结局
- Image Quality(6 Months Post Surgery)
研究者
Yajia Gu, MD
Director, Head of Radiology, Principal Investigator, Clinical Professor
Fudan University